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Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents

28. oktober 2021 oppdatert av: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase I/II Randomized Trial of the Safety and Immunogenicity of Cold Adapted Influenza Vaccine (FluMist) in HIV-Infected Children and Adolescents

The purpose of this study is to compare two flu vaccines to determine their safety and ability to stimulate an immune response in HIV infected children and adolescents. This study will also determine how often and how long people who receive a vaccine are able to spread flu vaccine virus to other people.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Influenza virus infections are common among children, particularly during the winter season. The infections are often mild, but more serious cases can cause a number of complications, including respiratory illnesses and bacterial infections. HIV infected children may have an increased risk for developing influenza-related bacterial complications, and influenza infections among this population may lead to more rapid disease progression. The current standard of care for HIV infected children is vaccination with an inactivated influenza vaccine (IAIV). However, IAIV is limited in its ability to stimulate the immune systems of HIV infected children with advanced disease. FluMist, a cold-adapted live attenuated influenza vaccine, is both immunogenic and effective in HIV infected children; unfortunately, FluMist is associated with viral shedding, a period of time when the influenza virus used to produce the vaccine may be transmitted to other people. This study will compare the safety and immunogenicity of IAIV and FluMist in HIV infected children and adolescents. This study will also determine the prevalence and duration of FluMist viral shedding in HIV infected children and adolescents who have received the vaccination.

Participants in this study will be randomly assigned to one of two arms. Arm A participants will receive FluMist; Arm B participants will receive IAIV. A single immunization will occur on Day 0 of the study. Arm A participants will have study visits on Days 3, 14, and 28 or home visits on Days 3 and 14. Participants in Arm B will have a study visit on Day 28. A physical exam will be performed at the initial study visit; blood will be collected at study start and at each visit thereafter. Phone calls will be made to participants throughout the study. All participants will have a final study visit after 6 months.

Studietype

Intervensjonell

Registrering

300

Fase

Fase 2
Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Alabama
  - Birmingham, Alabama, Forente stater, 35233
    - UAB, Dept. of Ped., Div. of Infectious Diseases
  - Mobile, Alabama, Forente stater
    - Univ. of South Alabama College of Medicine, Southeast Ped. ACTU
- Arizona
  - Phoenix, Arizona, Forente stater, 85006
    - Phoenix Children's Hosp.
- California
  - Long Beach, California, Forente stater, 90801
    - Long Beach Memorial Med. Ctr., Miller Children's Hosp.
  - Los Angeles, California, Forente stater, 90033
    - Usc La Nichd Crs
  - Los Angeles, California, Forente stater
    - UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
  - Oakland, California, Forente stater, 94609-1809
    - Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
  - Orange, California, Forente stater, 92868
    - Children's Hosp. of Orange County
  - San Diego, California, Forente stater, 92103
    - UCSD Maternal, Child, and Adolescent HIV CRS
  - San Francisco, California, Forente stater, 94143-0105
    - UCSF Pediatric AIDS CRS
  - Torrance, California, Forente stater, 90509
    - Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
- Colorado
  - Aurora, Colorado, Forente stater
    - Univ. of Colorado Denver NICHD CRS
- Connecticut
  - Hartford, Connecticut, Forente stater
    - Connecticut Children's Med. Ctr.
  - New Haven, Connecticut, Forente stater, 06504
    - Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
- District of Columbia
  - Washington, District of Columbia, Forente stater, 20010
    - Children's National Med. Ctr., ACTU
  - Washington, District of Columbia, Forente stater, 20060
    - Howard Univ. Washington DC NICHD CRS
  - Washington, District of Columbia, Forente stater, 20010
    - Children's National Med. Ctr. Washington DC NICHD CRS
- Florida
  - Fort Lauderdale, Florida, Forente stater, 33316
    - South Florida CDC Ft Lauderdale NICHD CRS
  - Fort Lauderdale, Florida, Forente stater
    - Children's Diagnostic & Treatment Ctr. of South Florida
  - Gainesville, Florida, Forente stater, 32610-0296
    - Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
  - Jacksonville, Florida, Forente stater, 32209
    - Univ. of Florida Jacksonville NICHD CRS
  - Miami, Florida, Forente stater, 33136
    - Univ. of Miami Ped. Perinatal HIV/AIDS CRS
  - Tampa, Florida, Forente stater, 33620
    - USF - Tampa NICHD CRS
- Georgia
  - Augusta, Georgia, Forente stater
    - Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
  - Columbus, Georgia, Forente stater, 31901
    - Columbus Regional HealthCare System, The Med. Ctr.
- Illinois
  - Chicago, Illinois, Forente stater, 60614
    - Chicago Children's CRS
  - Chicago, Illinois, Forente stater
    - Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
  - Chicago, Illinois, Forente stater
    - Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
- Louisiana
  - New Orleans, Louisiana, Forente stater, 70112-2699
    - Tulane/LSU Maternal/Child CRS
- Maryland
  - Baltimore, Maryland, Forente stater
    - Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
  - Baltimore, Maryland, Forente stater
    - Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
- Massachusetts
  - Boston, Massachusetts, Forente stater, 02115
    - HMS - Children's Hosp. Boston, Div. of Infectious Diseases
  - Boston, Massachusetts, Forente stater, 02118
    - BMC, Div. of Ped Infectious Diseases
  - Lawrence, Massachusetts, Forente stater, 01841-2884
    - Lawrence Family Health Ctr., Essex St. Clinic
  - Lowell, Massachusetts, Forente stater, 01854
    - Lowell Community Health Ctr.
  - Springfield, Massachusetts, Forente stater, 01199
    - Baystate Health, Baystate Med. Ctr.
  - Worcester, Massachusetts, Forente stater
    - WNE Maternal Pediatric Adolescent AIDS CRS
- Michigan
  - Detroit, Michigan, Forente stater, 48201
    - Children's Hospital of Michigan NICHD CRS
- Missouri
  - Saint Louis, Missouri, Forente stater, 63110
    - Washington Univ. School of Medicine at St. Louis, St. Louis Children's Hosp.
- New Jersey
  - Newark, New Jersey, Forente stater
    - NJ Med. School CRS
- New York
  - Bronx, New York, Forente stater, 10457
    - Bronx-Lebanon Hosp. IMPAACT CRS
  - Bronx, New York, Forente stater, 10461
    - Jacobi Med. Ctr. Bronx NICHD CRS
  - Bronx, New York, Forente stater, 10461
    - Jacobi Med. Ctr.
  - Brooklyn, New York, Forente stater, 11203-2098
    - SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
  - New York, New York, Forente stater, 10016
    - Nyu Ny Nichd Crs
  - New York, New York, Forente stater, 10037
    - Harlem Hosp. Ctr. NY NICHD CRS
  - New York, New York, Forente stater
    - Columbia IMPAACT CRS
  - New York, New York, Forente stater, 10029
    - Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases
  - Rochester, New York, Forente stater, 14642
    - Strong Memorial Hospital Rochester NY NICHD CRS
  - Stony Brook, New York, Forente stater, 11794-8111
    - SUNY Stony Brook NICHD CRS
  - Syracuse, New York, Forente stater, 13210
    - SUNY Upstate Med. Univ., Dept. of Peds.
- North Carolina
  - Chapel Hill, North Carolina, Forente stater, 27599-7220
    - UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
  - Durham, North Carolina, Forente stater, 27705
    - DUMC Ped. CRS
- Pennsylvania
  - Philadelphia, Pennsylvania, Forente stater, 19104-4318
    - The Children's Hosp. of Philadelphia IMPAACT CRS
- Tennessee
  - Memphis, Tennessee, Forente stater, 38105-2794
    - St. Jude/UTHSC CRS
- Texas
  - Houston, Texas, Forente stater, 77030
    - Texas Children's Hosp. CRS
- Virginia
  - Norfolk, Virginia, Forente stater, 23507
    - Children's Hosp. of the King's Daughters, Infectious Disease
- Washington
  - Seattle, Washington, Forente stater, 98105
    - UW School of Medicine - CHRMC
  - Seattle, Washington, Forente stater, 98105-0371
    - Seattle Children's Hospital CRS
Puerto Rico
- - San Juan, Puerto Rico
    - San Juan City Hosp. PR NICHD CRS
  - San Juan, Puerto Rico, 00936-5067
    - Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

5 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

HIV infected
Stable highly active antiretroviral therapy (HAART) regimen for at least 16 weeks with no changes in therapy anticipated
Meet certain CD4 cell count and CD4% requirements
Viral load of less than 60,000 copies/ml within 60 days prior to study start
Received inactivated influenza vaccine (IAIV) in at least one of the past 2 years
Written informed consent of parent or legal guardian
Availability of parent or legal guardian to be contacted by phone

Exclusion Criteria:

Immunosuppressive or immunomodulatory therapy within 60 days prior to immunization or immunological testing
Aspirin or aspirin-containing therapy at the time of vaccination or planned within 42 days after immunization
History of hypersensitivity to any component of IAIV or FluMist
History of Guillain-Barre syndrome
Receipt of any inactivated vaccine within 14 days prior to the study vaccination
Receipt of any live vaccine within 30 days prior to the study vaccination
Plans to receive any vaccine within the 30 days following the vaccination
Receipt of any additional influenza vaccine for the duration of the study
Prophylactic use of drugs with anti-influenza activity
Moderate chronic pulmonary disease, obstructive or restrictive
Cardiopulmonary disease affecting normal childhood activity
Medically-diagnosed wheezing, bronchodilator use, or steroid use within the past 42 days
Medical illness associated with suppression of T-cell immunity
Pregnancy, breast-feeding, or unwillingness to use acceptable methods of contraception for 3 months following vaccination
Severely immunosuppressed household member
Receipt of any blood products within 3 months prior to vaccination or expected receipt during the study, including the 6-month follow-up period
Significant fever or illness within 72 hours prior to vaccination
Any other condition that would interfere with the study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Forebygging
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbeidspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Etterforskere

Studiestol: Myron J. Levin, MD, University of Colorado, Denver

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiet fullført (Faktiske)

1. januar 2006

Datoer for studieregistrering

Først innsendt

16. september 2004

Først innsendt som oppfylte QC-kriteriene

17. september 2004

Først lagt ut (Anslag)

20. september 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

P1057
10612 (Annen identifikator: CTEP)
PACTG P1057

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .